FDA.reportPublic FDA data

JETPOLISHER 2000

Primary DI
07290016281767
Brand
JETPOLISHER 2000
Company
DELDENT LTD.
Model
QD - WH 1.1
Catalog number
519600
Device description
Dental Airpolishing Unit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014249000JETPOLISHERDeldent , Ltd.2002-02-19KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016281767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016281767072900162817677290016281767

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive air jet systemAn assembly of devices that together comprise a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600007124
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016281026MB coupling Midwest5051115051112022-11-22
07290016281033MB coupling Borden5051125051122022-11-22
07290016281040MB Quick coupling Kavo5051135051132022-11-22
07290016281057MB Quick coupling Sirona5051145051142022-11-22
07290016281064MB Quick coupling W&H5051175051172022-11-22
07290016281002Miniblaster Unit5050002016-09-24
07290016281019Miniblaster Nozzle Extension5051302016-09-24
07290016281705JETPOLISHER 2000BORDEN 1.15192002016-09-24
07290016281712JETPOLISHER 2000BORDEN 0.955192102016-09-24
07290016281729JETPOLISHER 2000MIDWEST 1.15193002016-09-24
07290016281736JETPOLISHER 2000MIDWEST 0.955193102016-09-24
07290016281743JETPOLISHER 2000 QD-S 1.15195002016-09-24
07290016281750JETPOLISHER 2000 QD-S 0.955195102016-09-24
07290016281774JETPOLISHER 2000QD - WH 0.955196102016-09-24
07290016281781JETPOLISHER 2000QD - K 1.15199002016-09-24
07290016281798JETPOLISHER 2000QD - K 0.955199102016-09-24
07290016281804JP/JST/JS HANDPIECE BOOSTER5091112016-09-24
07290016281811JP/JST/JS HANDPIECE REGULAR5091202016-09-24
07290016281835JETSTREAM POWDER5000045000042022-03-16
07290016281842JETSTREAM115 V5063002023-06-07

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Primary DI, Brand, Company table
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